Improving Recruitment and Retention for Diabetes Self-Management Education and Support

Sponsor

MedsPLUS Consulting (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05958602

Collaborator

Lister Hill Center for Health Policy (Other), Jenkins Public Health Consulting LLC (Other), National Institutes of Health (NIH) (NIH)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This randomized clinical trial aims to examine the effectiveness of utilizing CHWs (community health workers) and supplemental diabetes education technology to improve DSMES (diabetes self-management education and support) participation, retention, engagement, and clinical outcomes in adults in Jefferson County, AL living with diabetes. The main questions this study aims to answer are as follows:

Is the utilization of a multi-directional recruitment model via partnerships with community health workers and local primary care providers versus traditional recruitment methods (including using flyers, word of mouth, and media ads) effective in increasing recruitment and retention of people living with diabetes into a pharmacist-led DSMES program?
Is the utilization of the HICO Health Mobile application and provider dashboard as a supplementary tool alongside a standard DSMES curriculum effective at improving patient participation, retention, engagement, and clinical outcomes in a pharmacist-led DSMES program versus standard DSMES alone in Jefferson County, AL? After eligibility screenings and enrollment, participants will be randomized into two groups: one group will receive standard DSMES programming based on the 7 Self Care Behaviors and one group will receive standard DSMES programming and access to HICO Health, a diabetes-related mobile health application. The study team plans to evaluate whether a CHW- recruitment strategy will lead to an increase in referral and enrollment and whether incorporating the HICO Health application will lead to better retention, engagement, and clinical outcomes in terms of HbA1C levels.

This novel project will utilize continued stakeholder engagement, community health workers, and diabetes-related technology which we hope will increase the uptake and retention of participants in DSMES in Jefferson County, AL.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Diabetes Mellitus, Type 2	Behavioral: Technology Behavioral: Standard DSMES Only Behavioral: Traditional Recruitment Methods Behavioral: CHW-Led Recruitment Methods	N/A

Detailed Description

Diabetes is of increasing public health concern in Alabama due to high prevalence, incidence, and mortality rates. It was estimated that direct medical expenses for those diagnosed with diabetes in Alabama were about $4.2 billion in 2021 (American Diabetes Association, 2021). Due to the overall burden of the disease, there has been an increased focus on developing innovative strategies such as community-based interventions and diabetes education. The project aims to improve participation, retention, engagement, and clinical outcomes (HbA1C) of adults aged 18 and over living with diabetes in Jefferson County, Alabama in diabetes self-management education and support programs where the population lives, works, and plays. Leveraging a dynamic, multi-directional recruitment model through a collaborative partnership with community health workers (CHWs) and local primary care providers and a diabetes-related mobile application, the investigators plan to test, via a randomized controlled trial (RCT), the combined effects of a community health worker-led, muli-directional recruitment process versus a traditional recruiting process involving flyers, word-of-mouth, and media ads. The investigators also propose to assess the effectiveness of adding a diabetes-related mobile application (HICO Health) that, through a user-friendly interface, allows patients to review on-demand, evidence-based videos, nutrition education, and behavior change surveys to supplement standard DSMES curriculum, as well as a tool to collect patient entered clinical data such as blood pressure and blood sugar readings. The HICO Health package also includes a provider dashboard that allows the diabetes care team to monitor, in real-time, patient clinical data as well as communicate to patients via the HIPAA-compliant messaging function. The specific aims of the study are as follows: Aim 1: To examine the effectiveness of utilizing a multi-directional recruitment model involving community health workers and primary care providers versus traditional recruitment methods (including using flyers, word of mouth, and media ads) to recruit people living with diabetes into a pharmacist-led DSMES program. Aim 2: To conduct a pilot/feasibility study comparing using the HICO Health app as a supplement to a standard DSMES curriculum to improve patient participation, retention, and patient clinical outcomes in a pharmacist-led DSMES program versus the standard DSMES alone in Jefferson County, AL. Throughout the project, the study team and the diabetes care team will frequently communicate with the study stakeholders to seek input on relevant aspects of the study such as the engagement of CHWs, the stakeholders' perspective on the recruitment process, the number of participants referred and enrolled, and the clinical outcomes of the participants, to name a few. The evidence from the study will play a crucial role in establishing scalable and sustainable DSMES recruitment and delivery models to not only increase accessibility, participation, and retention in DSMES programs but also improve clinical outcomes in people living with diabetes in Jefferson County.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Improving Recruitment and Retention for Diabetes Self-Management Education and Support by Bridging Clinical-Community Linkages and Supplemental Diabetes Education Technology: A Socio-Ecological Approach

Anticipated Study Start Date :

Apr 1, 2024

Anticipated Primary Completion Date :

Feb 1, 2025

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Technology The interventional group will receive a standard, evidence-based DSMES curriculum and supplemental diabetes education-related technology to assess an improvement in participation, retention, engagement, and clinical outcomes (HbA1C).	Behavioral: Technology See previous response.
Active Comparator: Standard DSMES Only The control group will receive a standard, evidence-based DSMES curriculum only to assess an improvement in participation, retention, engagement and clinical outcomes (HbA1C)	Behavioral: Standard DSMES Only See previous response.
Active Comparator: Traditional DSMES Recruitment Methods The traditional DSMES recruitment method participants will be recruited using traditional methods such as flyers, word of mouth, and media ads to assess the effectiveness of traditional methods on recruiting and enrollment into to pharmacist-led DSMES programs.	Behavioral: Traditional Recruitment Methods See previous response.
Experimental: CHW-Led DSMES Recruitment Methods The CHW-led DSMES recruitment model participants will be recruited utilizing a CHW-led, multidirectional recruitment process involving community health workers (CHWs), primary care physicians, and community pharmacists to assess the effectiveness of a multidirectional recruitment process into pharmacist-led DSMES programs.	Behavioral: CHW-Led Recruitment Methods See previous response.

Outcome Measures

Primary Outcome Measures

Number of Referrals from Study Stakeholders [3 months]
Number of referrals from study stakeholders to DSMES programs in Jefferson County, AL.
Number of Participants Enrolled in DSMES Study [3 months]
Number of Participants Enrolled in DSMES Study
Number of DSMES Sessions Attended by Participants [2 months]
Number of DSMES sessions attended
Number of DSMES Participants with at Least 80% Session Retention [2 months]
Number of participants completing 4 of 5 DSMES sessions
Change in HbA1C of Participants [Baseline, 3 months, and 6 months]
Change in HbA1C

Secondary Outcome Measures

Change in Self-Care Knowledge [6 months]
Measure change in diabetes self-care knowledge utilizing the Diabetes Self-Management Questionnaire a 16-question survey broken down into 4 sub-scales (glucose management, dietary control, physical activity, and healthcare use). The rating scale utilizes a 4-point Likert scale ranging from 0 to 3 (where 0 means it does not apply to the participant and 3 means it applies to the participant very much). For each sub-scale, the minimum score is zero and the maximum score is 10, and higher scores are indicative of better self-care. Additionally, there is one item that requires participants to rate their perceived self-care using the 4-point Likert scale indicated above.
App Engagement [6 months]
Number of participants who used app at least two times a week during the intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Must be a resident of Jefferson County, Alabama
Must have an ICD-10 diagnosis of diabetes
Must have a primary care provider
Must be able to read, write, and converse in English
Must own and be able to utilize a smartphone with internet access
Must be willing to visit MedsPLUS Consulting in downtown Birmingham on 3 separate occasions (transportation may be provided, if approved).
Must be willing to attend and participate in five, two-hour education sessions over the course of 10 weeks

Exclusion Criteria:

Currently enrolled in a diabetes-related study
Currently enrolled in a lifestyle change program
Does not have or cannot get access to a home blood glucose monitor
Does not have or cannot get access to a smartphone with internet access

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

MedsPLUS Consulting
Lister Hill Center for Health Policy
Jenkins Public Health Consulting LLC
National Institutes of Health (NIH)

Investigators

Principal Investigator: Dashauna M Ballard, PhD, MPH, Lister Hill Center for Health Policy University of Alabama at Birmingham
Principal Investigator: Pauline K Long, PharmD, MedsPLUS Consulting LLC